This procedure is intended to assist manufacturers of vaccines and other biological products to electronically submit post marketing lot distribution data to FDA under 21 CFR 600.81. If vaccinators want less than 50 doses, they are instructed to list the extra doses they receive on the Wisconsin COVID-19 Vaccine Exchange. The dosing schedule approved by Health Canada is to give 2 doses (30 micrograms each for ages 12 and older or 10 micrograms each for ages 5 to 11) 21 days apart, based on evidence from clinical trials. Remember me? Please contact CDER Drug Shortage Staff at drugshortages@fda.hhs.gov with questions regarding this table. On Dec. 11, the US Food and Drug Administration issued its first emergency use authorization for a Covid-19 vaccine, shortly after the UK . This is the same process that is used to order all COVID-19 vaccines. Pfizer, Inc : Pfizer-BioNTech COVID-19 Vaccine/Comirnaty . The product has one dose per vial and 10 vials per carton. This is known as a mixed vaccine series. 153 0 obj <>/Filter/FlateDecode/ID[]/Index[125 52]/Info 124 0 R/Length 126/Prev 163118/Root 126 0 R/Size 177/Type/XRef/W[1 3 1]>>stream The Pfizer-BioNTech vaccine label remains for individuals aged 6 months to 11years since the vaccine is authorized but not yet approved for these age groups. Its safety and effectiveness in people younger than 6 months of age have not yet been established. First time users should review FDA's Electronic Submission Gateway (ESG) User Guide that provides industry participants with information and guidance on how to use the FDA ESG. Android, The best in medicine, delivered to your mailbox. On this date, Pfizer-BioNTech Comirnatytransitioned to an authorization under theFood and Drug Regulations. Home; Register; Login; Log in. Lot Number (EP6955): New Expiration Date: 9/30/2021 Lot Numbers (EN6207, ER8734, EW0150, ER8729, EW0158, ER8727, EW0162, ER8733): New Expiration Date: 10/31/2021. This placeholder date, which is far in the future, is intended to serve as a . If the test is not successful, review Step 2. At ImmunaBand, we always check the following: Not all sites use the standard CDC card. Review FDAs Draft Guidance for Industry: Electronic Submission of Lot Distribution Reports. Manufacturer Vaccine Name(s) NDC 10/NDC11 The National Drug Code (NDC) uniquely identifies human drugs in the United States; it can be found on the vial containing the vaccine. Thank you for taking the time to confirm your preferences. Companies may market their vaccines under brand names once approval is granted. How to search and advertise available COVID-19 vaccine for transfer (PDF) WAIIS online transfers (PDF) . The Pfizer SDVs have the same storage and handling requirements as with other Pfizer tris products (store at ultra-low temperature until expiry, may refrigerate up to 10 weeks within expiry period).